January 15, 2021

FDA extends comment period on 503B Bulks List

Last week, FDA announced that it was reopening the comment period for it’s proposed updated 503B Bulks List — the “bulk drug substances (active pharmaceutical ingredients) that FDA has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need.”

Comments can now be submitted until February 8, 2021, and APC is considering commenting.

Simply put: We welcome member input about what should be the substance of those comments. Nothing formal (on your end); all you need to do is send an email to scott@a4pc.org.